Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT

Multiple Sclerosis Clinical Trial

Official title:

Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03677440
• Other study ID #: IRB-300000111
• Secondary ID: 1R01HD091155-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: August 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

All participants will:

• Be between the ages of 18-65

• Have a clinically definite MS diagnosis based on established criteria

• Be fully-ambulatory based on Expanded Disability Status Scale (EDSS) scores between 0-4.0

• Demonstrate slowed CPS based on initial SDMT scores at least 1 SD below the regression-based normative score for healthy controls (i.e., 16th percentile)

• Be relapse-free and will not have acutely taken corticosteroids for at least 30 days (i.e., relative neurologic stability)

• Not have a history of major depressive disorder, schizophrenia, bipolar disorder I or II, or substance-abuse disorders.

• Not be taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines).

• Be right-handed

• Have corrected vision better than 20/80

• Not have known/diagnosed cardiovascular, metabolic, or renal disease. Individuals with known/diagnosed cardiovascular, metabolic, or renal disease who are asymptomatic will be included only with a physician's approval.

• Demonstrate scores on the Mini-Mental State Examination (MMSE) of 21 or higher (no decisional impairment)

• Be on a stable disease-modifying therapy regimen (i.e., at least 6 months prior to study enrollment).

• Have a low risk for contraindications for MRI based on not having metal (e.g., non-MRI compatible aneurysm clips, metal shards in the body or eyes, or recently placed surgical hardware) or electronic devices (e.g., pacemaker, cochlear implant) within the body.

• Not be pregnant

• Not be engaging in = 150 min of moderate-to-vigorous physical activity (i.e., not meeting public health guidelines for physical activity) per week

• Not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities

• Demonstrate systolic blood pressure values of < 200 mmHg or diastolic blood pressure values < 110 mmHg at rest

Related Conditions & MeSH terms

• Cognitive Impairment
• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Treadmill Walking Exercise Training
12-weeks of supervised, progressive treadmill walking exercise training
• Stretching-and-Toning Exercise Training
12-weeks of supervised, progressive stretching-and-toning exercise training

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Kessler Foundation	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Processing Speed	Raw (Total) Score from the Symbol Digit Modalities Test (0-110; higher scores indicate faster cognitive processing speed)	Every 12 weeks
Primary	Thalamocortical Resting-State Functional Connectivity Region 1	Functional connectivity between the thalamus and right medial frontal gyrus based on fMRI	Every 12 weeks
Primary	Thalamocortical Resting State Functional Connectivity Region 2	Resting-state functional connectivity between the thalamus and anterior cingulate cortex based on fMRI	Every 12 weeks